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PHR1437

Temozolomide

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Temozolomide, 3,4-Dihydro-3-methyl-4-oxoimidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3-Methyl-4-oxo-8-imidazolo[5,1-d][1,2,3,5]tetrazinecarboxamide, 4-Methyl-5-oxo-2,3,4,6,8-pentazabicyclo[4.3.0]nona-2,7,9-triene-9-carboxamide, 8-Carbamoyl-3-methylimidazo[5,1-d]-1,2,3,5-tetrazin-4(3H)-one, NSC 362856

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About This Item

Empirical Formula (Hill Notation):
C6H6N6O2
CAS Number:
85622-93-1
Molecular Weight:
194.15
NACRES:
NA.24
PubChem Substance ID:
329822600
UNSPSC Code:
41116107
MDL number:
MFCD00866492

Key Documents

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Product Name

Temozolomide, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C6H6N6O2/c1-11-6(14)12-2-8-3(4(7)13)5(12)9-10-11/h2H,1H3,(H2,7,13)

SMILES string

CN1N=Nc2c(ncn2C1=O)C(N)=O

InChI key

BPEGJWRSRHCHSN-UHFFFAOYSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to USP 1643543

API family

temozolomide

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

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Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Application

Temozolomide may be used as a pharmaceutical reference standard for the determination of the analyte in drug dosage forms by reverse phase liquid chromatography and UV spectrophotometry.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.
Temozolomide is an alkylating agent of the imidazotetrazine group. It is a chemotherapy drug, used in the treatment of anaplastic astrocytoma, glioblastoma multiforme and malignant metastatic melanoma, which works by arresting cancer cell growth.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAA2745 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazardExclamation mark
GHS08,GHS07

signalword

Danger

Hazard Classifications

Acute Tox. 4 Oral - Carc. 1B - Eye Irrit. 2 - Muta. 1B - Repr. 1B - Skin Irrit. 2 - STOT SE 3

target_organs

Respiratory system

Storage Class

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

wgk

WGK 3

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Development and Validation of Simultaneous Detrmination of Anastrozole and Temozolomide in Pharmaceutical Dosage Forms.
Daphal VN, et al.
International Journal of Theoretical & Applied Sciences, 4(2), 48-55 (2012)
Development and validation of UV method of temozolomide in bulk and capsule formulation.
Razak AA, et al.
International Journal of Pharmaceutical Sciences and Research, 4(4), 1419-1423 (2013)
Design of experiment based validated stability indicating RP-HPLC method of temozolomide in bulk and pharmaceutical dosage forms.
Khan A, et al.
Beni-Suef University Journal of Basic and Applied Sciences, 5(4), 402-408 (2016)
Yun-Yu Chen et al.
Translational oncology, 14(1), 100897-100897 (2020-10-18)
Zinc(II)-dipicolylamine (Zn-DPA) has been shown to specifically identify and bind to phosphatidylserine (PS), which exists in bulk in the tumor microenvironment. BPRDP056, a Zn-DPA-SN38 conjugate was designed to provide PS-targeted drug delivery of a cytotoxic SN38 to the tumor microenvironment
Reshma Rangwala et al.
Autophagy, 10(8), 1369-1379 (2014-07-06)
Blocking autophagy with hydroxychloroquine (HCQ) augments cell death associated with alkylating chemotherapy in preclinical models. This phase I study evaluated the maximum tolerated dose (MTD), safety, preliminary activity, pharmacokinetics, and pharmacodynamics of HCQ in combination with dose-intense temozolomide (TMZ) in
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